Efficacy and Safety of High-Concentration 35 kDa Hyaluronan Gel for Chronic Nasopharyngitis: A Prospective Clinical Study

NCT07568548 | Not Yet Recruiting

• 1 other identifier: HA35202601
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a prospective, single-arm, open-label, pilot clinical study to evaluate the efficacy and safety of nasopharyngeal administration of 13.6% high-concentration 35 kDa hyaluronan (HA35) care gel in subjects with chronic rhinitis and chronic pharyngitis. Eligible participants will receive the study gel twice daily for 10 consecutive days. The primary objectives are to assess rapid changes in nasopharyngeal discomfort, posterior pharyngeal discomfort, and nasal obstruction within 30 minutes after the first administration. Secondary objectives include evaluation of overall symptom improvement at day 10, changes in subjective mental clarity, and safety and tolerability throughout the treatment period. This is a minimal-risk, non-pharmacological supportive care intervention.

Conditions

Chronic Rhinitis; Chronic Pharyngitis; Nasopharyngitis; Posterior Pharyngeal Inflammation; Nasal Obstruction

Keywords

Hyaluronan; 35 kDa Hyaluronan; HA35; Nasopharyngeal Care; Chronic Rhinitis; Chronic Pharyngitis; Nasal Congestion; Pharyngeal Discomfort; Non-pharmacological Intervention; Pilot Clinical Study

Outcome Measures

Primary Outcomes (1)

• Change in Posterior Pharyngeal Discomfort and Cough NRS Score (0-10)

  Change in posterior pharyngeal discomfort and associated cough intensity, measured using a 0-10 Numeric Rating Scale (NRS), where 0 = no discomfort/cough and 10 = worst imaginable discomfort/cough.

  Baseline to 30 minutes after first administration

Study Arms (1)

HA35 Nasopharyngeal Care Gel Intervention Group

EXPERIMENTAL

Participants will receive 13.6% high-concentration 35 kDa hyaluronan (HA35) nasopharyngeal care gel, administered via the nasopharyngeal route, one unit per nostril, twice daily (morning and evening) for 10 consecutive days. The intervention is non-pharmacological and designed to evaluate efficacy and safety in subjects with chronic rhinitis and chronic pharyngitis.

Device: 13.6% High-Concentration 35 kDa Hyaluronan (HA35) Nasopharyngeal Care Gel

Interventions

13.6% High-Concentration 35 kDa Hyaluronan (HA35) Nasopharyngeal Care Gel DEVICE

A topical, non-pharmacological nasopharyngeal care gel containing 13.6% high-concentration 35 kDa hyaluronan. It is designed to support mucosal hydration and reduce inflammation in the nasopharynx. Administration is via direct nasopharyngeal application, twice daily for 10 consecutive days.

Also known as: HA35 Nasopharyngeal Gel; HA35 Care Gel

HA35 Nasopharyngeal Care Gel Intervention Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-80 years, male or female
• Clinically diagnosed with chronic rhinitis and chronic pharyngitis for ≥3 months
• Baseline nasopharyngeal discomfort NRS score ≥4 points
• Baseline posterior pharyngeal discomfort NRS score ≥4 points
• Voluntary participation and signed written informed consent
• Ability to complete symptom assessment independently

You may not qualify if:

• Acute upper respiratory tract infection within 2 weeks
• Use of antihistamines, intranasal corticosteroids, decongestants, or other nasal medications within 2 weeks prior to screening
• History of nasal/sinus surgery within 6 months
• Known hypersensitivity to hyaluronan or any gel ingredients
• Pregnant or lactating women
• Severe systemic diseases or malignant tumors

Sponsors & Collaborators

• Nakhia Impex LLC: lead

MeSH Terms

Conditions

Nasopharyngitis; Nasal Obstruction

Condition Hierarchy (Ancestors)

Pharyngitis; Respiratory Tract Infections; Infections; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Nose Diseases; Airway Obstruction; Respiratory Insufficiency; Respiration Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2026
• First Posted: May 5, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04